Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - locametz

Document Subject

Generated Narrative: MedicinalProductDefinition mp6f21bde7c462d7396cfc7185d72d2377

identifier: http://ema.europa.eu/identifier/EU/1/22/1692/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Locametz 25 micrograms kit for radiopharmaceutical preparation

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6f21bde7c462d7396cfc7185d72d2377

identifier: http://ema.europa.eu/identifier/EU/1/22/1692/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - locametz

Attesters

What is in this leaflet

1. What Locametz is and what it is used for
2. What you need to know before Locametz is used
3. How Locametz is used
4. Possible side effects
5. How Locametz is stored
6. Contents of the pack and other information

What Locametz is This medicine is a radiopharmaceutical product for diagnostic use only.

Locametz contains a substance called gozetotide. Before use, gozetotide (the powder in the vial) is coupled with a radioactive substance called gallium-68 to make gallium (68Ga) gozetotide solution (this procedure is called radiolabelling).

What Locametz is used for After radiolabelling with gallium-68, Locametz is used in a medical imaging procedure called positron emission tomography (PET) to detect specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:

• to find out whether prostate cancer has spread to lymph nodes and other tissues outside the prostate, before primary curative therapy (e.g. therapy involving surgical removal of the prostate, radiation therapy)
• to identify cancer cells when recurrence of prostate cancer is suspected in patients who have received primary curative therapy
• to find out whether patients with progressive metastatic castration-resistant prostate cancer may be suitable for a specific therapy, called PSMA-targeted therapy

How Locametz works When given to the patient, gallium (68Ga) gozetotide binds to the cancer cells that have PSMA on their surface and makes them visible to your nuclear medicine doctor during the PET medical imaging procedure. This gives your doctor and nuclear medicine doctor valuable information about your disease.

The use of gallium (68Ga) gozetotide involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

If you have any questions about how Locametz works or why this medicine has been prescribed for you, ask your nuclear medicine doctor.

Locametz must not be used

• if you are allergic to gozetotide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your nuclear medicine doctor before you receive Locametz if you have any other type of cancer, as this could affect the interpretation of the image.

The use of Locametz involves exposure to a small amount of radioactivity. Repeated exposure to radiation may increase the risk of cancer. Your nuclear medicine doctor will explain necessary radioprotection measures to you (see section 3).

Before administration of Locametz you should

• Drink plenty of water so that you remain hydrated and urinate immediately before the PET medical imaging procedure, and as often as possible during the first hours after administration.

Children and adolescents This medicine should not be given to children or adolescents aged under 18 years because no data are available in this age group.

Pregnancy and breast-feeding Locametz is not intended for use in women. All radiopharmaceuticals, including Locametz, have the potential to cause harm to an unborn baby.

Driving and using machines It is considered unlikely that Locametz will affect your ability to drive or to use machines.

Locametz contains sodium This medicine contains 28.97 mg sodium (main component of cooking/table salt) in each injection. This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Locametz will only be used in special controlled areas. This radiopharmaceutical product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this radiopharmaceutical product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of Locametz to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended for an adult is 1.8-2.2 MBq (megabecquerel, the unit used to express radioactivity) per kg of body weight, with a minimum amount of 111 MBq and a maximum of 259 MBq.

Administration of Locametz and conduct of the procedure After reconstitution and radiolabelling, Locametz is given as a slow injection into a vein. You will undergo a PET scan starting 50 to 100 minutes after you have received Locametz.

Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Locametz, you should

• Continue to drink plenty of water so that you remain hydrated and urinate as often as possible to eliminate the radiopharmaceutical product from your body.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Locametz than you should An overdose of Locametz is unlikely because you will only receive a single dose that is precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the event of an overdose, you will receive the appropriate treatment. You may be asked to drink and urinate frequently in order to eliminate the radiopharmaceutical product from your body.

Should you have any further question on the use of Locametz, please ask the nuclear medicine doctor who supervises the procedure.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects include the following listed below. If these side effects become severe, please tell your nuclear medicine doctor.

Common (may affect up to 1 in every 10 people)

• tiredness (fatigue)

Uncommon (may affect up to 1 in every 100 people)

• nausea
• constipation
• vomiting
• diarrhoea
• dry mouth
• reactions at the site of injection, such as bruising, itching and warmth (injection site reactions)
• chills

This radiopharmaceutical product will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

Reporting of side effects If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceutical products will be in accordance with national regulations on radioactive materials.

The following information is intended for the specialist only:

• Locametz must not be used after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
• Before reconstitution, store below 25 C.
• After reconstitution and radiolabelling, store upright below 30 C. Use within 6 hours.

What Locametz contains

• The active substance is gozetotide. One vial contains 25 micrograms of gozetotide. The other ingredients are: gentisic acid, sodium acetate trihydrate and sodium chloride (see Locametz contains sodium in section 2).

What Locametz looks like and contents of the pack Locametz is a multidose kit for radiopharmaceutical preparation containing one vial of white freeze-dried powder (powder for solution for injection).

Gallium-68 is not part of the kit.

After reconstitution and radiolabelling, Locametz contains a sterile solution for injection of gallium (68Ga) gozetotide at an activity of up to 1 369 MBq.

After reconstitution, the gallium (68Ga) gozetotide solution for injection also contains hydrochloric acid.

Pack size: 1 vial.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Advanced Accelerator Applications (Italy) S.R.L. Via Crescentino snc 13040 Saluggia (VC) Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SAM Nordic vedija Tel: +46 8 720 58
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika M.G.P. spol. s r.o. Tel: +420 602 303 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark SAM Nordic Sverige Tel: +46 8 720 58 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Radiopharmaceuticals GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SAM Nordic Rootsi Tel: +46 8 720 58 Norge SAM Nordic Sverige Tlf: +46 8 720 58

: +30 22920 63 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Advanced Accelerator Applications Ib rica, S.L.U. Tel: +34 97 6600 Polska Advanced Accelerator Applications Polska Sp. z o.o. Tel.: +48 22 275 56 France Advanced Accelerator Applications T l: +33 1 55 47 63 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland SAM Nordic Sv j
S mi: +46 8 720 58 Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Advanced Accelerator Applications (Italy) S.r.l Tel: +39 0125 561Suomi/Finland SAM Nordic Ruotsi/Sverige Puh/Tel: +46 8 720 58

: +30 22920 63Sverige SAM Nordic Tel: +46 8 720 58 Latvija SAM Nordic Zviedrija Tel: +46 8 720 58 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: